NCT01883583

Brief Summary

To check the possibility of the acquisition of a number of parameters through real-time contrast-enhanced ultrasound and sonoelastography images and to verify the correlation with pathologic results from ultrasound guided biopsy of transplanted kidney

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2013

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2013

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

June 15, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 21, 2013

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

November 6, 2013

Status Verified

November 1, 2013

Enrollment Period

11 months

First QC Date

June 15, 2013

Last Update Submit

November 5, 2013

Conditions

Transplant; Failure, Kidney

Keywords

UltrasoundPerfusion ImagingElasticity Imaging TechniquesKidney TransplantationGraft RejectionChronic allograft nephropathy

Outcome Measures

Primary Outcomes (1)

  • Acquisition of time-intensity curve(TIC) using contrast-enhanced ultrasound

    The day of admission (within 24hours)

Study Arms (1)

Pilot group

EXPERIMENTAL

Contrast-enhanced Ultrasound And Sonoelastography of transplanted kidney will be performed for acquisition of a number of parameters and time-intensity curves, before ultrasound guided biopsy of transplanted kidney.

Device: Contrast-enhanced Ultrasound And Sonoelastography

Interventions

Contrast-enhanced Ultrasound And SonoelastographyDEVICE

Before ultrasound guided biopsy of transplanted kidney, we will perform conventional, Sonoelastography and real-time contrast-enhanced ultrasound using Sonovue for acquisition of parameters and data, respectively.

Pilot group

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • )Patients to perform ultrasound guided biopsy of transplanted kidney

You may not qualify if:

  • )Patients to have the medical histories of heart such as acute failure, arrhythmia, ischemia, infarction and angioplasty 2)Patients to show poor graft function which does not recovery within three days after transplantation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, 110-744, South Korea

RECRUITING

MeSH Terms

Interventions

Elasticity Imaging Techniques

Intervention Hierarchy (Ancestors)

UltrasonographyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Jeong Yeon Cho, Professor

    Department of Radiology, Seoul National University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jeong Yeon Cho, Professor

CONTACT

82-2-2072-3074radjycho@snu.ac.kr

Sang Youn Kim, Professor

CONTACT

82-2-2072-3321iwishluv@empas.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 15, 2013

First Posted

June 21, 2013

Study Start

June 1, 2013

Primary Completion

May 1, 2014

Study Completion

December 1, 2015

Last Updated

November 6, 2013

Record last verified: 2013-11

Locations

KR(1)